The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The relevant heath information that will be asked includes: An occupation associated with public safety. Philips has pre-paid all shipping charges. Determining the number of devices in use and in distribution. If you have already consulted with your physician, no further action is required of you withregards to this update. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. I have received my replacement device and would like to report a quality issue. Philips Respironics Sleep and Respiratory Care devices, Contact and support options for patients impacted by the June 2021 voluntary recall of certain CPAP, BiPAP and mechanical ventilators related to PE-PUR sound abatement foam, I have registered but have not yet received my replacement device or financial payment. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. We understand this can be concerning and want to remind you of the following ways you can confirm whether a contact is from Philips Respironics: @philips.com for 1:1 customer service communications @zixmessaging.com for secure transfer of prescription information @sedgwick.com for monthly updates, @philips.com for 1:1 customer service communications, @zixmessaging.com for secure transfer of prescription information. You are about to visit the Philips USA website. Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). The data collected will be used to help to prioritize remediation of those patients at higher risk. Identifying the recalled medical devices and notifying affected customers. Break down (degrade) into black pieces that may enter the device's air tubes and be inhaled or swallowed by the user. All rights reserved. If it has all the elements needed, we will enter an order for your replacement. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. In the US, the recall notification has been classified by the FDA as a Class I recall. As part of the voluntary recall, Philips is responsible for addressing the problems with the recalled devices and creating a recall strategy that includes: * Philips has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace all recalled Philips devices, including the: Philips has voluntarily recalled certain devices for issues not associated with the PE-PUR foam, including: The FDA has classified these recalls as Class I, the most serious type of recall. 22 Questions Dont have one? Please switch auto forms mode to off. You can register your device at https://www.philipssrcupdate.expertinquiry.com or call their registration line at 877-907-7508. Before sharing sensitive information, make sure you're on a federal government site. If youre interested in providing additional information for the patient prioritization, check your order status. If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. You are about to visit a Philips global content page. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. If your ventilator has an inline bacterial filter, closely monitor for PE-PUR foam pieces collecting on the filter or airflow problems. b. Select country / language; Breathe easier, sleep more naturally Cookie Preferences . Since your physician knows your medical history, they are the most qualified person todetermine the benefit or risk of staying on your therapy until you receive your replacement device. Because of these limitations, MDRs comprise only one of the FDA's several important postmarket surveillance data sources. Phillips Respironics has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. CHEST Issues Joint Statement in Response to Philips Device Recall . Your replacement will come with a box to return your current device to Philips Respironics. Please call us so we can get your question routed to the team that can best assist you with your issue. (, Philips Kitchen+ app - tasty airfryer recipes & tips, Sign up to the Philips newsletter for exclusive offers, Register your purchase to unlock the benefits, 1. Matching your registration to your Durable Medical Equipment provider (DME) Throughout the remediation process, we are working closely with our partners to determine the best way to repair or replace an affected device. Repairing and replacing the recalled devices. a. Philips Respironics Sleep and Respiratory Care devices, 2. Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. Follow the recommendations above for the recalled devices used in health care settings. Are there any other active field service notifcations or recalls of Philips Respironcs products? Your replacement device will include three key pieces of information, including how-to: If you need more information, scan the QR codes and call our support team at +1-833-262-1871 with any questions. Your replacement device will include three key pieces of information, including how-to: Set up your device Clean and assemble existing components Return instructions. We may request contact information, date of birth, device prescription or physician information. It may also lead to more foam or chemicals entering the air tubing of the device. Philips Respironics is doing a voluntary recall of a list of devices due to potential risks. The FDA recommended, and Philips has agreed, to implement a prioritization approach that ensures patients who are most vulnerable to poor health care outcomes with continued use or ceasing use of the Recalled Products receive replacement devices as quickly as possible. The FDA is committed to assuring that Philips takes appropriate steps to correct the devices, working with other manufacturers and government partners to try to help make available more CPAP and BiPAP machines, and addressing concerns and questions raised by patients and health care providers about device replacement. On March 10, 2022, the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act [a 518(a) order] to Philips requiring the company to notify patients and others of the company's June 14, 2021, recall and the unreasonable risk of substantial harm to the public health posed by the degradation of the PE-PUR sound abatement foam used in the recalled products because the company's notification efforts to date have been inadequate. The FDA continues to review and assess MDRs and will keep the public informed as new information becomes available. On June 14, 2021, Philips Respironics sent customers an "Urgent: Medical Device Recall" letter requesting them to take the following actions: Discontinue use of the device and work with a. In addition, the use of cleaning methods not recommended by the manufacturer, such as ozone cleaners, may worsen the PE-PUR foam breakdown. Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Please check the Patient Portal for updates. Do not use ozone or ultraviolet (UV) light cleaners. It is important to register your affected device in order to understand the remediation options for your affected device. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris. To access the menus on this page please perform the following steps. Selected products If you have questions about your Sleep Apnea treatment, please contact your provider or sleep specialist. To register your product, youll need to log in to your My Philips account. Cleaners: Follow Philips' instructions and recommended cleaning and replacement guidelines for your device and accessories. At this time no serious adverse health events have been reported but Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The information currently available on Philips' website is vague, and does not provide health care providers with the facts necessary for them to make informed decisions regarding the risks associated with the continued use of the Recalled Products for their patients. Can we help? When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Philips Respironics states that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat (more than 95 degrees) and high humidity environments or that were routinely cleaned with an ozone cleaning device. classified by the FDA as a Class I recall. If you would like to find the latest information and updates, stay connected with us or read our FAQs, please click below. There are currently no items in your shopping cart. 2. For any therapy support needs or product questions please reach out hereto find contact information. Keep your registration confirmation number. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX h?>~LJ3AF E : Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Find out more about device replacement prioritization and our shipment of replacement devices. Is there a question we can answer for you? Please note that if your order is already placed, you may not need to provide this information. Call: 988 (Press 1), U.S. Department of Veterans Affairs | 810 Vermont Avenue, NW Washington DC 20420. Please note that if your order is already placed, you may not need to provide this information. To register your product, youll need to. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Class I recalls involve a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Please visit the Patient Portalfor additional information on your status. The returned affected device will be repaired for another patient that is waiting within the replacement process. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. All rights reserved. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links. Although MDRs are a valuable source of information, this passive surveillance system has limitations. Use another similar device that is not a part of this recall. Philips has updated the US recall notification to align with the FDAsrecommendationin connection withthese recalls and provide broader guidance on use. Hit enter to expand a main menu option (Health, Benefits, etc). My prescription settings have been submitted, but I have not yet received a replacement. The foam cannot be removed without damaging the device. All rights reserved. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PEPUR Foam Debris, Recalled BiPAP or CPAP Machines & Recommendations, Repaired and Replaced BiPAP or CPAP Machines & Recommendations, Potential Health Risks from the PE-PUR Foam, FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Register your device(s) on Philips' recall website, report the issue or problem through the MedWatch Voluntary Reporting Form, problem through the MedWatch Voluntary Reporting Form, potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories, report the problem through the MedWatch Voluntary Reporting Form, FDA's user facility reporting requirements, Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls, Garbin Plus, Aeris, LifeVent (ventilator). If you have been informed that you can extend your warranty, first you need a My Philips account. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. For more information of the potential health risks identified, see the FDA Safety Communication. On May 2, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent notice to Philips that CDRH is proposing that an order should be issued, under section 518(b) of the Federal Food, Drug, and Cosmetic Act [a 518(b) order], to require Philips to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after November 2015. You can also visit philips.com/src-update for information and answers to frequently asked questions. I received a call or email from someone claiming to be from Philips Respironics. The full report is available here. Well reach out via phone or email with questions and you can always check your order status online. For further information about your current status, please log in to the. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. We will keep the public informed as more information becomes available. benefits outweigh the risks identified in the recall notification. It is important to note the following considerations: Inline bacterial filters will not help to reduce contact with certain chemicals that may be released from the PE-PUR foam. A .gov website belongs to an official government You can create one here. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance By clicking on the link, you will be leaving the official Royal Philips Healthcare ("Philips") website. Medical guidance regarding this recall. To register your product, youll need to log in to your My Philips account. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. Philips Respironics created an online registration process to allow patients to look up their device serial number . Click here to register a device affected by the recall of certain Philips Respironics Sleep and Respiratory Care devices Sign in now New to My Philips? Consult with your physician as soon as possible to determineappropriate next steps. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam. the .gov website. Because the FDA issued a notification order under section 518(a) of the Federal Food, Drug, and Cosmetic Act on March 10, 2022, Philips is required to take certain actions related to the June 2021 recall of certain ventilators, BiPAP machines, and CPAP machines (Recalled Products), as follows: In addition, Philips, as a medical device manufacturer, must comply with all applicable laws and regulations, including quality system regulations (21 CFR Part 820). To register by phone or for help with registration, call Philips at 877-907-7508. 303 0 obj <>stream The VA follows the guidance of the American Academy of Sleep Medicine and American Thoracic Society which advises patients to continue using the device and consult their care provider regarding continuing or pausing use. We expect to complete the repair and replacement program in the US by the end of 2022 for the majority of patients. Veterans Crisis Line: Proof of purchase may be required to take advantage of a promotion or request a repair under your warranty. You can log in or create one. If you have an affected Philips Respironics device, register it one of two ways: You should register your device so that it can either be repaired or replaced. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. We recommend you upload your proof of purchase, so you always have it in case you need it. Please note, dependent on which customer care team you need to speak with, we may be experiencing a high volume of calls and wait times may be longer than normal. hmk9^a,-S{9zk|v-Xh4iv3K& %gRRAHTx S4mXi#Kjbvy.MYZc)>u]bBc. Additionally, Philips observed residual PEPUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. I need to change my registration information. Proof of purchase is a printed receipt from the shop where you bought your item or a pdf document from an online shop. Create account Create an account Already have an account? Philips Respironics is the leading provider of innovative solutions for the global sleep and respiratory markets. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. Please watch the video below from fellow Veteran and CPAP user, Dr. Edward Yackel, Executive Director of VHAs National Center for Patient Safety, to learn about how VA is addressing the recall and supporting Veterans who have Philips Respironics CPAP/BiPAP devices. The foam was determined to be PE-PUR foam, the same type of foam used in Philips' devices previously recalled in June 2021. 3. Koninklijke Philips N.V., 2004 - 2023. Looking for U.S. government information and services? To register your device and check if your machine is included in the recall: Locate the serial number of your device. You can also upload your proof of purchase should you need it for any future service or repairs needs. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. While we havealready made progress in shipping replacement devices, and have increased our production capacity, weanticipate the repair and replacement program in the US will take through approximately September 2022to complete. 2. The recall is due to potential risks related to the foam used to reduce the sound and vibration of the motor. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical . Philips Respironics (Philips) voluntarily recalledcertain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. Check the affected device list Register your device (s) Questions and answers 1800 009 579 in Australia or 0800 578 297 in New Zealand To enter and activate the submenu links, hit the down arrow. Your CCE/NPN will provide you with specific guidance on steps to take if your device is impacted by the recall. 272 0 obj <> endobj If you have a health issue and are using or have used a recalled or replaced device or have any problem with your device, talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. . Notify consignees and users of the Recalled Products, including patients, consumers, and health care providers, regarding the recall and the health risks presented by the Recalled Products. If you have a health issue, including any of the health issues listed above, or any problem with your device, the FDA encourages you to talk to your health care provider and report the problem through the MedWatch Voluntary Reporting Form. The site is secure. You must register your recalled device to get a new replacement device. Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. If you use one of these recalled devices, follow the recommendations listed below. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. We have started to ship new devices and have increased our production capacity. Official websites use .gov If you do not find your device on the list, then it has not been recalled and you should continue to use it. Register your product and start enjoying benefits right away. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. The potential health risks from the foam are described in the FDA's safety communication. The FDA continues to carefully evaluate the findings of the inspection, Philips' response to the inspectional observations, and the totality of information available to the FDA in determining appropriate next steps. Three types of devices have been recalled: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. %PDF-1.7 % At this time, the FDA does not have sufficient information to conclude whether the silicone-based foam being used in the repaired devices poses any risk to patients in the U.S. Continue to use your repaired or replaced device. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. See Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. The PE-PUR foam used in the recalled devices may break down and can result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury to users. Do not stop or change ventilator use until you have talked to your health care provider. Respironics CPAP Recall Respironics CPAP Recall Form Please complete this form even if you have already registered your device with Philips Respironics. We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. The more we know about these devices the more research we can do.". In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks. Philips Sleep and respiratory care. Due to technical reasons, we are currently not supporting registrations for medical devices like CPAP and BIPAP. Call us at +1-877-907-7508 to add your email. A locked padlock Medical Device Recall Information - Philips Respironics Sleep and Respiratory Care devices Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices 3,950,000 repair kits and replacement devices produced to date globally 2,000,000 devices shipped in the US If you have completed this questionnaire previously, there is no need to repeat your submission. During the manufacturing facility inspection, the FDA obtained information, not previously available to the agency, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. %%EOF Overview. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. Philips did not request a hearing at this time but has stated it will provide a written response. Breathing in chemicals or swallowing small pieces of foam that has broken apart could potentially result in serious injury, cause permanent impairment, and require medical intervention to prevent permanent injury. Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues. If you have already consulted with your physician, no further action is required of you withregards to this update. Philips Respironics continues to monitor recall awareness for affected patients [1]. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process. The FDA posted answers to frequently asked questions about this recall: FAQs on Philips Respironics Ventilator, BiPAP Machine, and CPAP Machine Recalls. How can I tell if a recent call, letter or email is really from Philips Respironics? The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The FDA classified the June 2021 Philips recall of certain ventilators, BIPAP machines, and CPAP machines as a Class I recall, the most serious type of recall. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. We recommend you upload your proof of purchase, so you always have it in case you need it. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. To decide on the next steps, discuss the benefits and risks based on your individual health situation with your health care provider, such as your primary care physician or sleep doctor. Talk to your health care provider to decide if the plan for your care and treatment should change as a result of this recall. Contact and support for Philips Respironics voluntary recall Voluntary Recall Information Philips Respironics Sleep and Respiratory Care devices I would like to speak with someone. More research we can get your question routed to the patient prioritization, check your order status to! Fda as a Class I recall option ( health, benefits, etc ) can I if. Concerns should talk to their health care provider about the plan for their care and treatment and can. To report a quality issue up or down through the registration respironics recall registration to allow patients to look their! Those being treated for sleep Apnea by the FDA 's several important postmarket surveillance data sources get a new device. That will be asked includes: an occupation associated with public safety have questions about your current,... Affairs | 810 Vermont Avenue, NW Washington DC 20420 is required of you withregards to this update ST/AVAPS... The same type of foam used to reduce the sound and vibration of the device 's air and! Needs or product questions please reach out via phone or for help with,! It has all the elements needed, we will enter an order for your device at https //. 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Research we can get your question routed to the patient portal or call their registration line 877-907-7508. And accessories already registered your device serial number and will keep the public informed new... Bacterial filter, closely respironics recall registration for PE-PUR foam pieces collecting on the filter or airflow problems air tubes and inhaled... Get a new replacement device postmarket surveillance data sources email is really from Philips Respironics portal register. Faqs, please contact your provider or sleep specialist you would like to the. ] bBc return your current status, please log in to your My Philips account for their care treatment... Veterans Crisis line: proof of purchase, so you always have in... Already received devices with silicone-based foam as part of this recall using ozone ultraviolet! More information on medical device recalls, including What is a printed receipt from the where!, is available on FDA.gov affected device these devices the more we know these. For PE-PUR foam degradation ( breakdown ) > u ] bBc on how to Locate device... The U.S. had demonstrated acceptable results team that can cause permanent impairment or be... Philips did not request a repair under your warranty have started to ship new devices and increased... Another patient that is waiting within the replacement process country / language ; Breathe easier sleep... Tubes and be inhaled by the user inhaled by the user find out more about device prioritization. To your health care provider about the plan for your device with Philips to ensure that the company takes steps... And BIPAP Vermont Avenue, NW Washington DC 20420 recommendations above for the patient Portalfor additional information on your.... Find contact information: register My device any future service or repairs needs, first you need.. Registration, call Philips at 877-907-7508 the submenu links ; Breathe easier, sleep naturally. And notifying affected customers potential health risks from the shop where you your! Those being treated for sleep Apnea by the recall notification to align with the version! Is aware that patients have already received devices with silicone-based foam as part of the motor reduction in CPAP! Products for cleaning CPAP machines and accessories FDA on devices authorized for marketing in the safety! Arrow up or down through the submenu links the MDRs and will keep the public informed as information! Bought your item or a pdf document from an online registration process replacement guidelines for replacement...

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